510(k) K863447

STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II by Stryker Corp. — Product Code GET

K863447 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II". The FDA issued a decision of Substantially Equivalent on September 29, 1986. The device falls under product code GET (Motor, Surgical Instrument, Pneumatic Powered), a Class I device regulated under 21 CFR 878.4820. Stryker Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1986
Date Received
September 8, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Pneumatic Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type